13 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

ADVANTAGE 4D OPTION

FDA 510(k)
FDA Class 2 ·Radiology

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091032915·Baltic Denture System BDLoad ↓ Sm7 PLSEum6DFs B...

Mini Master Series

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746161827·DB BKT MINI MS V-SLOT LR CUSP 022 T-7 A+7 R3D

FLEXIBLE OCCLUSION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

DINAMAP PRO 1000 MONITOR, MODEL 1000

FDA 510(k)
FDA Class 2 ·Cardiovascular

MICROMAX-PLUS MOTOR ASSY

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code ERL·March 29, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 29, 2011

N'VISION

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·April 23, 2008

LIFEPAK CR(R) PLUS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·December 21, 2017

SURGPN,270X5,HMPMPC,-,LFR-CS,24

FDA Adverse Event
Injury ·HALYARD - IRVINE·Product code MEB·November 26, 2015

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

FDA Enforcement
Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024